BEUDAMED
    FDA Recall Terminated

    Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    Recall: Z-0259-2018 · Initiated August 31, 2017

    Recall

    Recall Number
    Z-0259-2018
    Event Number
    78784
    Firm
    Orthoscan, Inc.
    FEI Number
    3005254598
    Product Code
    OXO
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 31, 2017
    Terminated
    April 21, 2021
    Address
    8212 E Evans Rd, Scottsdale, AZ, 85260-3670

    Description

    Mobile Mini C-arm system Part # 1000-0004. Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.

    Reason

    OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user

    Action

    Orthoscan sent an Urgent Recall Notice, dated August 30, 2017, to customers, informing them of the issue and how to address it. Customers are to use the attached list of serial numbers to determine if their device is affected. Customers may continue to use their affected device with caution until the on-site correction has been made. Users should avoid non-conforming workflows by taking the measures outlined in the letter. The firm will contact customers to arrange implementation of the corrective action at no cost to the customer. If there are further questions or concerns, please call National Customer Service Team at (866) 949-4346.

    Distribution

    Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.

    Quantity

    2012 total